WO2016153957A3 - Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases - Google Patents

Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases Download PDF

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Publication number
WO2016153957A3
WO2016153957A3 PCT/US2016/023021 US2016023021W WO2016153957A3 WO 2016153957 A3 WO2016153957 A3 WO 2016153957A3 US 2016023021 W US2016023021 W US 2016023021W WO 2016153957 A3 WO2016153957 A3 WO 2016153957A3
Authority
WO
WIPO (PCT)
Prior art keywords
fumarates
compositions
treatment
methods
intravenous administration
Prior art date
Application number
PCT/US2016/023021
Other languages
French (fr)
Other versions
WO2016153957A2 (en
Inventor
Ajay Verma
Robert Scannevin
Shyam Karki
Fengmei ZHENG
Original Assignee
Biogen Ma Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to MX2017012239A priority Critical patent/MX2017012239A/en
Application filed by Biogen Ma Inc. filed Critical Biogen Ma Inc.
Priority to EA201792076A priority patent/EA201792076A1/en
Priority to JP2017549232A priority patent/JP2018508559A/en
Priority to AU2016235743A priority patent/AU2016235743A1/en
Priority to CN201680028617.1A priority patent/CN107666905A/en
Priority to KR1020177029928A priority patent/KR20170138437A/en
Priority to US15/559,265 priority patent/US20180289655A1/en
Priority to EP16715662.9A priority patent/EP3270895A2/en
Priority to CA2979544A priority patent/CA2979544A1/en
Publication of WO2016153957A2 publication Critical patent/WO2016153957A2/en
Publication of WO2016153957A3 publication Critical patent/WO2016153957A3/en
Priority to IL254576A priority patent/IL254576A0/en
Priority to HK18104073.2A priority patent/HK1244680A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/695—Silicon compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Psychology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Disclosed herein are methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases, such as stroke, amyotrophic lateral sclerosis, Huntington's disease, Alzheimer's disease, Parkinson's disease, and Multiple Sclerosis.
PCT/US2016/023021 2015-03-20 2016-03-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases WO2016153957A2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
KR1020177029928A KR20170138437A (en) 2015-03-20 2016-03-18 Method and composition for intravenous administration of fumarate for the treatment of neurological diseases
EA201792076A EA201792076A1 (en) 2015-03-20 2016-03-18 METHODS AND COMPOSITIONS FOR INTRAVENOUS ADMINISTRATION OF FUMARATES FOR THE TREATMENT OF NEUROLOGICAL DISEASES
JP2017549232A JP2018508559A (en) 2015-03-20 2016-03-18 Methods and compositions for intravenous administration of fumarate esters for the treatment of nervous system disorders
AU2016235743A AU2016235743A1 (en) 2015-03-20 2016-03-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases
CN201680028617.1A CN107666905A (en) 2015-03-20 2016-03-18 Fumarate is applied to treat the method and composition of sacred disease for intravenous
MX2017012239A MX2017012239A (en) 2015-03-20 2016-03-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases.
US15/559,265 US20180289655A1 (en) 2015-03-20 2016-03-18 Methods and Compositions for the Intravenous Administration of Fumarates for the Treatment of Neurological Diseases
EP16715662.9A EP3270895A2 (en) 2015-03-20 2016-03-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases
CA2979544A CA2979544A1 (en) 2015-03-20 2016-03-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases
IL254576A IL254576A0 (en) 2015-03-20 2017-09-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases
HK18104073.2A HK1244680A1 (en) 2015-03-20 2018-03-23 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562136431P 2015-03-20 2015-03-20
US62/136,431 2015-03-20

Publications (2)

Publication Number Publication Date
WO2016153957A2 WO2016153957A2 (en) 2016-09-29
WO2016153957A3 true WO2016153957A3 (en) 2016-11-10

Family

ID=55702079

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/023021 WO2016153957A2 (en) 2015-03-20 2016-03-18 Methods and compositions for the intravenous administration of fumarates for the treatment of neurological diseases

Country Status (15)

Country Link
US (1) US20180289655A1 (en)
EP (1) EP3270895A2 (en)
JP (1) JP2018508559A (en)
KR (1) KR20170138437A (en)
CN (1) CN107666905A (en)
AR (1) AR104029A1 (en)
AU (1) AU2016235743A1 (en)
CA (1) CA2979544A1 (en)
EA (1) EA201792076A1 (en)
HK (1) HK1244680A1 (en)
IL (1) IL254576A0 (en)
MA (1) MA41785A (en)
MX (1) MX2017012239A (en)
TW (1) TW201642847A (en)
WO (1) WO2016153957A2 (en)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005023241A1 (en) * 2003-09-09 2005-03-17 Fumapharm Ag The use of fumaric acid derivatives for treating cardiac insufficiency, and asthma
WO2006037342A2 (en) * 2004-10-08 2006-04-13 Aditech Pharma Ab Controlled release pharmaceutical compositions comprising a fumaric acid ester
WO2008096271A2 (en) * 2007-02-08 2008-08-14 Ralf Gold Neuroprotection in demyelinating diseases
WO2013090799A1 (en) * 2011-12-16 2013-06-20 Biogen Idec Ma Inc. Silicon-containing fumaric acid esters
WO2013119677A1 (en) * 2012-02-07 2013-08-15 Biogen Idec Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
CN103768045A (en) * 2013-10-30 2014-05-07 苏州大学附属第一医院 Application of dimethyl fumarate to preparation of medicine for treating early brain injury (EBI) after subarachnoid hemorrhage (SAH)
US20140179779A1 (en) * 2012-12-21 2014-06-26 Biogen Idec Ma Inc. Deuterium Substituted Fumarate Derivatives
US20150079180A1 (en) * 2013-09-18 2015-03-19 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
WO2016074684A1 (en) * 2014-11-11 2016-05-19 Syddansk Universitet Fumaric acid derivatives for medical use

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US4959389A (en) 1987-10-19 1990-09-25 Speiser Peter P Pharmaceutical preparation for the treatment of psoriatic arthritis
DE19721099C2 (en) 1997-05-20 1999-12-02 Fumapharm Ag Muri Use of fumaric acid derivatives
CA2478458A1 (en) 2004-08-20 2006-02-20 Michael Panzara Treatment of pediatric multiple sclerosis
WO2007042035A2 (en) 2005-10-07 2007-04-19 Aditech Pharma Ab Combination therapy with fumaric acid esters for the treatment of autoimmune and/or inflammatory disorders
US20080089861A1 (en) 2006-07-10 2008-04-17 Went Gregory T Combination therapy for treatment of demyelinating conditions
ES2916649T3 (en) * 2007-02-08 2022-09-21 Biogen Ma Inc Compositions and uses for the treatment of multiple sclerosis
EP2671891A3 (en) 2008-06-27 2014-03-05 Amgen Inc. Ang-2 inhibition to treat multiple sclerosis
EP2650279A3 (en) 2008-08-19 2014-02-12 XenoPort, Inc. Prodrugs of methyl hydrogen fumarate, pharmaceutical compositions thereof, and methods of use
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WO2005023241A1 (en) * 2003-09-09 2005-03-17 Fumapharm Ag The use of fumaric acid derivatives for treating cardiac insufficiency, and asthma
WO2006037342A2 (en) * 2004-10-08 2006-04-13 Aditech Pharma Ab Controlled release pharmaceutical compositions comprising a fumaric acid ester
WO2008096271A2 (en) * 2007-02-08 2008-08-14 Ralf Gold Neuroprotection in demyelinating diseases
WO2013090799A1 (en) * 2011-12-16 2013-06-20 Biogen Idec Ma Inc. Silicon-containing fumaric acid esters
WO2013119677A1 (en) * 2012-02-07 2013-08-15 Biogen Idec Ma Inc. Pharmaceutical compositions containing dimethyl fumarate
US20140179779A1 (en) * 2012-12-21 2014-06-26 Biogen Idec Ma Inc. Deuterium Substituted Fumarate Derivatives
US20150079180A1 (en) * 2013-09-18 2015-03-19 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
CN103768045A (en) * 2013-10-30 2014-05-07 苏州大学附属第一医院 Application of dimethyl fumarate to preparation of medicine for treating early brain injury (EBI) after subarachnoid hemorrhage (SAH)
WO2016074684A1 (en) * 2014-11-11 2016-05-19 Syddansk Universitet Fumaric acid derivatives for medical use

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Also Published As

Publication number Publication date
CA2979544A1 (en) 2016-09-29
CN107666905A (en) 2018-02-06
US20180289655A1 (en) 2018-10-11
EP3270895A2 (en) 2018-01-24
JP2018508559A (en) 2018-03-29
TW201642847A (en) 2016-12-16
KR20170138437A (en) 2017-12-15
AR104029A1 (en) 2017-06-21
MA41785A (en) 2018-01-23
MX2017012239A (en) 2018-06-27
HK1244680A1 (en) 2018-08-17
AU2016235743A1 (en) 2017-10-12
IL254576A0 (en) 2017-11-30
WO2016153957A2 (en) 2016-09-29
EA201792076A1 (en) 2018-04-30

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